This is a primary, comprehensive textbook for people who are considering undertaking a piece of health-related research. It is an accessible companion with the aim of getting the reader to think broadly about all of the issues that need to be considered when embarking on a project. This is a pragmatic book, a step-by-step guide to research which mirrors the structure of a research project, taking you through the thought process for designing and conducting your study from formulating the right research question at idea inception, ascertaining what methodologies and analysis can answer what type of questions, right through to dissemination, all presented in an easy, digestible style. The book is full of case study illustrations and practical tips such as how to work out a research budget and obtaining funding for your project, discussion of what permissions need to obtained when conducting research with people, and how to involve public and patients. The authors are all experienced researchers and so this book is an accumulation of collective wisdom on common research challenges and issues.
Chapter 11: Clinical Trials
- Describe what is meant by a clinical trial
- Understand the reasons for randomisation and the methods of treatment allocation
- Describe the characteristics, advantages, and disadvantages of main clinical trial designs
- Understand the principles underlying the choices of outcome variables and interventions
- Be aware of threats to the validity of trial conclusions
- Outline the principles of trial analysis and reporting
A clinical trial is an experiment performed on humans with the aim of obtaining a convincing answer to a medical question. The medical question will refer to the effect of an intervention, for example, drug, surgery, public health programme, health service reorganisation, etc., on the outcome in a particular disease or condition that each participant has. Trials are not applicable for studies of prognostic ...